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510(k) Data Aggregation

    K Number
    K080833
    Device Name
    LOVE GUARD MALE LATEX CONDOM
    Date Cleared
    2008-08-07

    (135 days)

    Product Code
    Regulation Number
    884.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    TIANJIN HUMAN-CARE LATEX CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This latex condom has the same intended use as the predicate condom. This condom is used for contraception and for prophylactic purposes to help prevent pregnancy and the transmission of sexually transmitted diseases. If used properly, this condom will help to reduce the risk of transmission of HIV infection and many other sexually transmitted diseases including syphilis, chlamydia infections, genital herpes, genital warts, gonorrhea, hepatitis B. etc.
    Device Description
    This condom is made of a natural latex sheath, which completely covers the penis with a closely fitted membrane. This condom is straight-walled with a reservoir tip. Its nominal length is 185 - 190 mm, nominal width 50.5 -51.5 mm, and nominal thickness 0.06 - 0.08 mm. It is offered in natural latex color and lubricated with polydimethylsiloxane (silicone) with cornstarch as the dressing material. This condom is designed to conform to established American and international voluntary standards including ASTM D3492 and ISO 4074.
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